Clinical Research Associate

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

A healthier future. That's what drives us.

The Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies. You will work independently to ensure studies are delivered, recorded and reported in accordance with protocol, standard operating procedures, good clinical

practices and other applicable regulatory requirements.

The Opportunity:

• You will act as the main point of contact and clinical trial expert for assigned study site personnel. Provide training, coordinate certification, and offer technical assistance as needed.

• You will conduct site assessments and participate in the site selection process to ensure suitability for the study and facilitate site activation by ensuring proper contracting, obtaining necessary approvals from IRB/EC/Health Authorities, and maintaining regulatory compliance.

• Develop key study site documents such as the Study Monitoring Plan, informed consent documents, source documents, patient instruction guides, and case report forms. Contribute technical expertise in the review of study protocols, data management plans, reports, and manuscripts.

• Collaborate with various departments including R&D, Field Service, Study Management, Biometrics, etc. to deliver the best solutions. Also, perform data generation/validation and site monitoring activities in accordance with regulations and processes.

Who you are:

• Bachelor's degree in scientific discipline or related field required and minimum 3 years of experience in clinical research

• Demonstrate technical expertise in Personalized Health Care Studies, specifically Digital Pathology, and electronic Trial Master File and Electronic Data Capture tools used in clinical trials.

• Demonstrate expertise in relevant standards and regulations for clinical trials and lab conduct (ICH-GCP, FDA Regulations, IVDR).

• Work across CDMA Clinical Operations communities to identify mutual value and opportunities for collaboration.

• Ensure adherence to ICH and GCP guidelines in the execution of clinical trials and/or other associated project

Relocation benefits are not being offered for this position.

The expected salary range for this position of $77,800 - $144,600 is based on the primary location of Tucson, AZ. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.
Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.